There is now some help at hand to those struggling to bring their cholesterol under control as a breakthrough cholesterol-lowering treatment that promises to drastically reduce LDL-C (low-density lipoprotein cholesterol) in the blood or ‘bad’ cholesterol has been launched in India.
Inclisiran, which has got approval from the Drug Controller General of India (DCGI), has been termed as a futuristic drug and is only required to be taken twice a year. However, it costs around `1.2 lakh per dose.
While a majority of patients in India with LDL-C - a well-known factor for heart attacks and strokes - are now taking statins, this new drug, which is already available in the US, UK, and Europe since 2021 as Leqvio, promises to reduce LDL-C by 50-60%, said Dr J P S Sawhney, chairman, department of cardiology, Sir Ganga Ram Hospital, New Delhi.
“Inclisiran is the best in a new class of gene-silencing drugs, which helps in reducing LDL cholesterol and increase HDL (high-density lipoproteins) cholesterol or good cholesterol,” said Dr Anand R Shenoy, consultant interventional cardiologist, Manipal Hospitals, Bengaluru.
He said the injectable turns off PCSK9 enzymes, boosting the liver’s ability to remove harmful cholesterol from the blood, adding, “In the long term, the new medicine will help reduce the risk of blocks and heart attacks in high-risk individuals.” Produced by Swiss pharma giant Novartis and sold under the brand name Sybrava in India, inclisiran is for subcutaneous single injection by into the abdomen, upper arm or thigh. The recommended dose is 284 mg. Another dose follows after three months and then every six months.
“Elevated LDL-C or bad cholesterol is not only an important risk factor in cardiovascular diseases, but also the cause for atherosclerotic cardiovascular diseases (ASCVD). This innovative medicine has the potential to change the practice of medicine in treating ASCVD patients,” said Amitabh Dube, president and MD of Novartis India.
Cardiovascular diseases (CVDs), which are a leading cause of death worldwide, claim nearly 18 million lives each year. “India accounts for one-fifth of these deaths. Coronary Artery Disease (CAD) occurs at a younger age in Indians, with over 50% of CVD mortality occurring in individuals aged less than 50 years,” he said.
According to a study conducted by the Indian Council and Medical Research and Madras Diabetes Research Foundation and published in The Lancet last year, 213 million people, or almost 24% of the Indian population, have dyslipidemia, a disorder marked by abnormal levels of lipids, like cholesterol, LDL-C, HDL-C and triglycerides in the blood. This condition can result from diet, tobacco exposure or genetics and can lead to cardiovascular disease with severe complications.
According to Dr Prafulla Kerkar, consultant cardiologist at Asian Heart Institute, Mumbai, and a member of the Dyslipidemia Guidelines Committee of the Cardiological Society of India and Lipid Association of India, LDL-C should be lowered at an early age, as it will help reduce lifelong risk of major adverse cardiovascular events - non-fatal heart attack, stroke and cardiovascular death.
“It is a known fact that Indians are more prone to ASCVD, CAD and myocardial infarction,” he said.
He said this drug is for those whose cholesterol has not gone down despite being on statins, who have recurrent or family history, or experience excessive side effects from statins. He added that it can’t be called a silver bullet –like penicillin - and will have to wait for the outcome data. “I can say the biggest advantage is that it comes as a vaccine dosage. Despite giving statins, people are still dying of heart attacks and brain strokes. So the best thing to do is to lower LDL further by taking preventive steps.”
Experts, however, said the cost will affect its accessibility. “The high cost of inclisiran may pose a challenge, and affordability could influence widespread adoption,” said Dr Vivek Chaturvedi, head, department of cardiology, Amrita Hospital, Faridabad.
Moreover, there are cheaper generic medicines in India. “Numerous affordable medications are accessible to lower cholesterol levels efficiently. Statins, extensively studied and highly effective, are the primary choice due to their well-established track record and ability to lower LDL, and are readily accessible,” Dr Chaturvedi said.
“Additionally, there are two other oral options - histamine and the newer bampidoic acid - utilised either in conjunction with or occasionally as alternatives to statins, particularly in statin-associated muscle symptoms,” he added.
Evolocumab (sold under the brand name Repatha) – the novel PCSK9 inhibitor – is also available in India. Costing around `18,000 per injection, it is also indicated for use by statin-intolerant patients or those with high bad cholesterol despite using statins. It is to be administered as an injection every 15 days.
Dr Sawhney added that compared to 26 injections of PCSK9 inhibitors, two doses of inclisiran are more cost-effective. “It improves adherence and makes it more affordable.”
However, concerns have been raised about possible side effects which may only present itself after several years of use. “Possible adverse effects that might be noticed after several years of treatment because the activity of inclisiran persists for six months, making it challenging to reverse any potential long term side effects,” said Dr Sanjeeva Kumar Gupta, consultant, cardiology, C K Birla Hospital, New Delhi. “Furthermore, in all trials so far, inclisiran was used together with oral drugs, so in practice, at least initially, inclisiran would be used together with oral drugs and not as a replacement treatment,” he added.
Experts, however, were unanimous on prevention is better than cure. “To prevent high cholesterol, the focus should be on lifestyle changes such as a healthy diet, regular exercise and avoiding smoking,” said Dr Kerkar.
Now in india
Inclisiran is a cholesterol-lowering drug that reduces levels of LDL cholesterol in the blood
It is a gene-silencing drug as that silences the gene PCSK9, which in turn boosts the liver’s ability to remove harmful cholesterol from the blood
After an initial dose, the drug is given again after three months and then twice a year
Each 284 mg dose is administered using a single pre-filled syringe.
Recommended for
Those whose cholesterol has not gone down despite being on statin
Have recurrent or family history of cardiovascular events
Experience too many statin side effects and are unable to take them.
Side effects
Local injection site reactions
Some muscle-associated symptoms
Symptoms like a common cold with inflammation in the nasal passages
Headaches